Federal Register Summary for week of 24 September

Commerce

Listing Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List Atlantic Bluefin Tuna as Threatened or Endangered under the Endangered Species Act

AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.

ACTION: 90-day petition finding; request for information.

SUMMARY: We, NMFS, announce a 90-day finding for a petition to list
Atlantic bluefin tuna (Thunnus thynnus) as endangered or threatened
under the Endangered Species Act (ESA) and to designate critical
habitat concurrently with a listing. We find that the petition presents
substantial scientific information indicating the petitioned action may
be warranted. We will conduct a status review of Atlantic bluefin tuna
to determine if the petitioned action is warranted. To ensure that the
review is comprehensive, we solicit information pertaining to this
species from any interested party.

DATES: Information related to this petition finding must be received
by November 22, 2010.

ADDRESSES: You may submit comments, identified by RIN 0648-XW96, by
any of the following methods:

All comments received are a part of the public record and will
generally be posted to http://www.regulations.gov without change. All Personal
Identifying Information (for example, name, address, etc.) voluntarily
submitted by the commenter may be publicly accessible. Do not submit
Confidential Business Information or otherwise sensitive or protected
information.

Notice of Availability of a Draft NOAA Climate Service Strategic Vision and Framework for Public Review, and Notice of Informational Webinar Meetings

ACTION: Notice of availability of a draft NOAA Climate Service
strategic vision and framework for public review, and notice of
informational webinar meetings.

SUMMARY: On February 8, 2010, the Department of Commerce and the
National Oceanic and Atmospheric Administration (NOAA) announced their
intent to establish a new NOAA Climate Service (NCS). The new service
will directly support NOAA's vision of "an informed society that uses
a comprehensive understanding of the role of the oceans, coasts, and
atmosphere in the global ecosystem to make the best social and economic
decisions.'' It will also contribute to NOAA's mission "to understand
and anticipate changes in Earth's environment, and conserve and manage
coastal and marine resources to meet our Nation's economic, social and
environmental needs.'' The reorganization of existing agency assets is
intended to help NOAA better work with our partners to respond to the
growing demands for climate information from the public, business,
industry, local, state and Federal agencies, and decision makers.

As part of the process to establish a new NCS, NOAA recently
completed a strategic vision and framework document that describes how
NOAA proposes to respond to society's growing need for climate
services. The document describes the vision and outlines how the NCS
can achieve new strategic goals related to the delivery and development
of reliable, timely, and authoritative climate science and service to
enable a climate-resilient society to grow and prosper.

NOAA will accept comments on the strategic vision from September 21
to midnight on October 18, 2010. A copy of the draft document and
instructions on how to submit comments can be found at http://www.noaa.gov/climate.

is also hosting a series of informational webinars for
individuals and organizations to learn more about the proposed NCS
vision and timeline and to provide an opportunity for to answer
questions, and obtain feedback. Each webinar is targeted to a specific
sector, and will begin with a presentation from Dr. Chet Koblinsky,
Director, NOAA Climate Program Office and Transitional Deputy Director,
NOAA Climate service, and will be followed by a question and answer
session.

DATES: The webinar meeting dates are:
1. Friday, September 24, 2010, 1 p.m. to 2:30 p.m. EST, for the
academic research community.
2. Friday, September 24, 2010, 3 p.m. to 4:30 p.m. EST, for state
and local government officials.
3. Wednesday, September 29, 2010, 3:30 p.m. to 5 p.m. EST, for the
corporate and business community.
4. Thursday, September 30, 2010, 3:30 p.m. to 5 p.m. EST, for non-
governmental and non-profit organizations.

For specific instructions for each webinar, please visit http://www.noaa.gov/climateresources/meetings. Additional information about
the proposed NOAA Climate Service, including questions and answers can
be found at http://www.noaa.gov/climate.

Environmental Protection Agency

SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing
the public release of the 2010 version of the Causal Analysis/Diagnosis
Decision Information System (CADDIS). This Web site was developed to
help scientists find, develop, organize, and use environmental
information to improve causal assessments of biological impairment. The
CADDIS Web site was developed and prepared by EPA's National Center for
Environmental Assessment (NCEA), in the Office of Research and
Development (ORD), and is available at http://www.epa.gov/caddis.

DATES: The 2010 CADDIS Web site will become publically available on
September 24, 2010.

DATES: Nominations should be submitted by October 15, 2010 per
instructions below.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this Notice and Request for Nominations
may contact Ms. Iris Goodman, Designated Federal Officer (DFO), SAB
Staff Office, by telephone/voice mail at (202) 564-2164, by fax at
(202) 565-2098, or via e-mail at goodman.iris@epa.gov. General
information concerning the EPA Science Advisory Board can be found at
the EPA SAB Web site at http://www.epa.gov/sab.

Health and Human Services

Clinical Investigator Training Course

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA), Office of Critical
Path Programs, in cosponsorship with the Clinical Trials Transformation
Initiative (CTTI), is announcing a 3-day training course for health
care professionals responsible for, or involved in, the conduct and/or
design of clinical trials (clinical investigators). This course is
intended to assist clinical investigators in understanding what
preclinical and clinical information is needed to support the
investigational use of medical products, as well as the scientific,
regulatory, and ethical considerations involved in the conduct of
clinical trials.

DATES: The training course will be held on November 8 and 9, 2010,
from 8 a.m. to 5 p.m. and on November 10, 2010, from 8 a.m. to 3 p.m.

ADDRESSES: The training course will be held at the National Labor
College, 10000 New Hampshire Ave., Silver Spring, MD 20993-0002.

Registration: Register by November 1, 2010, at the registration/
information Web site at https://www.trialstransformation.org/fda-clinical-investigator-training-course/. Registration materials, payment
procedures, accommodation information, and a detailed description of
the course can be found at the registration/information Web site. The
registration fee is $350 per person. The fee includes course materials
and onsite lunch. Early registration is recommended because seating is
limited. There will be no onsite registration. Persons attending the
course are advised that FDA is not responsible for providing access to
electrical outlets. If you need special accommodations due to a
disability, please contact Nancy Masiello at least 7 days in advance.

Draft Revision of the Federalwide Assurance

AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health, Office for
Human Research Protections.

ACTION: Notice.

SUMMARY: The Office for Human Research Protections (OHRP), Office of
the Assistant Secretary for Health, is announcing the availability of
the draft revised Federalwide Assurance (FWA) form and Terms of
Assurance, and is seeking comment on these draft documents. OHRP is
proposing several changes to simplify and shorten the FWA form and
Terms of Assurance. Institutions engaged in non-exempt human subjects
research conducted or supported by the Department of Health and Human
Services (HHS) must hold an OHRP-approved FWA. The draft revised FWA
form and Terms of Assurance, when finalized, will supersede the current
FWA documents available on the OHRP Web site at
http://www.hhs.gov/ohrp/assurances/assurances_index.html. OHRP
will consider comments received before implementing any revisions to
the FWA documents.

DATES: Submit written comments by October 25, 2010.

ADDRESSES: Submit written requests for single copies of the draft
revised FWA form and Terms of Assurance to the Division of Policy and
Assurances, Office for Human Research Protections, 1101 Wootton
Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed
adhesive label to assist that office in processing your request, or fax
your request to 301-402-2071. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the draft revised FWA
documents.

You may submit comments, identified by docket ID number HHS-OPHS-
2010-0023, by one of the following methods:

Federal eRulemaking Portal:
http://www.regulations.gov. Enter the above docket ID number in
the "Enter Keyword or ID'' field and click on "Search.'' On the next
web page, click on the "Submit a Comment'' action and follow the
instructions.

Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues

AGENCY: Office for Human Research Protections, Office of the Assistant
Secretary for Health, Office of the Secretary, Department of Health and
Human Services.

ACTION: Notice.

SUMMARY: The Office for Human Research Protections (OHRP), within the
Office of the Assistant Secretary for Health, is announcing the
availability of a guidance document entitled, "Guidance on Withdrawal
of Subjects From Research: Data Retention and Other Related Issues.''
The guidance document provides OHRP's first formal guidance on this
topic. The document, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/policy/subjectwithdrawal.html or http://www.hhs.gov/ohrp/policy/subjectwithdrawal.pdf, is intended primarily for
institutional review boards (IRBs), investigators, and funding agencies
that may be responsible for the review or oversight of human subject
research conducted or supported by the Department of Health and Human
Services (HHS). The guidance document announced in this notice
finalizes the draft guidance entitled, "Guidance on Important
Considerations for When Participation of Human Subjects in Research is
Discontinued,'' that was made available for public comment through a
notice in the Federal Register on December 1, 2008 (73 FR 72804). OHRP
received comments on the draft guidance document from 30 individuals
and organizations, and those comments were considered as the guidance
was finalized.

DATES: Comments on OHRP guidance documents are welcome at any time.

ADDRESSES: Submit written requests for a single copy of the guidance
document entitled, "Guidance on Withdrawal of Subjects From Research:
Data Retention and Other Related Issues,'' to the Division of Policy
and Assurances, Office for Human Research Protections, 1101 Wootton
Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed
adhesive label to assist that office in processing your request, or fax
your request to 301-402-2071. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance document.

Submit written comments to COMMENTS ON SUBJECT WITHDRAWAL GUIDANCE,
Office for Human Research Protections, 1101 Wootton Parkway, Suite 200,
Rockville, MD 20852. Comments also may be sent via e-mail to
ohrp@hhs.gov or via facsimile at 240-402-2071.

Office of Biotechnology Activities, Office of Science Policy, Office of the Director; Notice of Meeting

Pursuant to section 10(a) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the meeting of the
National Science Advisory Board for Biosecurity (NSABB).

Name of Committee: National Science Advisory Board for
Biosecurity.

Date: October 19, 2010.

Time: 8:30 a.m. to 4 p.m. Eastern Daylight Time (Times are
approximate and subject to change).

Agenda: Presentations and discussions regarding: (1) Update of
Federal activities relevant to the mission of the NSABB; (2)
activities of NSABB Working Groups on Codes of Conduct; Culture of
Responsibility; International Engagement; Journal Review Policies;
and Outreach and Education; (3) consideration of advances in
synthetic biology in relation to NSABB recommendations regarding
biosecurity concerns raised by this field; (4) planning for future
NSABB meetings and activities; and (5) other business of the Board.

Under authority 42 U.S.C. 217a, Section 222 of the Public Health
Service Act, as amended, the Department of Health and Human Services
established the NSABB to provide advice, guidance and leadership
regarding federal oversight of dual use research, defined as
biological research that generates information and technologies that
could be misused to pose a biological threat to public health and/or
national security.

The meeting will be open to the public, however pre-registration
is strongly recommended due to space limitations. Persons planning
to attend should register online at: http://oba.od.nih.gov/biosecurity/biosecurity_meetings.html or by calling Palladian
Partners, Inc. (Contact: Joel Yaccarino at 301-650-8660.)
Individuals who plan to attend and need special assistance, such as
sign language interpretation or other reasonable accommodations,
should indicate these requirements upon registration.

Any member of the public interested in presenting oral comments
relevant to the mission of the NSABB at the meeting may notify the
Contact Person listed on this notice at least 10 days in advance of
the meeting. Interested individuals and representatives of an
organization may submit a letter of intent, a brief description of
the organization represented, and a short description of the oral
presentation. Only one representative of an organization may be
allowed to present oral comments. Both printed and electronic copies
are requested for the record. In addition, any interested person may
file written comments relevant to the mission of the NSABB. All
written comments must be received by October 12, 2010 and should be
sent via e-mail to nsabb@od.nih.gov with "NSABB Public Comment'' as
the subject line or by regular mail to 6705 Rockledge Drive, Suite
750, Bethesda, MD 20892, Attention: Ronna Hill. The statement should
include the name, address, telephone number and, when applicable,
the business or professional affiliation of the interested person.

Contact Person: Lee L. Zwanziger, Office of Policy, Planning and
Preparedness, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, rm. 3278, Silver Spring, MD, 20993, 301-796-9151, FAX: 301-
847-8611, e-mail: RCAC@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 8732112560. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.

Agenda: On November 8 and 9, 2010, the Committee will hear and
discuss developments in FDA's ongoing communications programs, such as
FDA's Strategic Plan for Risk Communication, FDA's Transparency
Initiative, and the challenges of effectively communicating with
patients and caregivers about appropriate use of medical devices when a
patient is prescribed a medical device for home use.

FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.

Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 29, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on November 8, 2010, and 10:30
to 11:30 a.m. on November 9, 2010. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before October 21, 2010. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by October
22, 2010.

Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.

FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Lee Zwanziger at
least 7 days in advance of the meeting.